NEURENT MEDICAL LIMITED

FDA Device Registration & Listing · Galway, IE · Registration 3016813690

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016813690
FEI Number
3016813690
Entity Name
NEURENT MEDICAL LIMITED
City/State/Country
Galway, IE
Establishment Address
Neurent Medical, No. 1 Oranpoint, Oranmore, Galway H91 D7X2, IE
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Neurent Medical Limited (Owner Number: 10083199)
Owner / Operator Contact Address
Neurent Medical, No. 1 Oranpoint, Oranmore, Galway, IE-G H91 D7X2, IE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K261833
PMA Number
N/A

All Registered Proprietary Names

NEUROMARK System Neuromark System NEUROMARK System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-05-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-12-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2026-06-18

Official Correspondent

Kenny Walsh

US Agent Details

Erika Nelson Email: Erika.Nelson@neurentmedical.com Phone: (617) 7591331

Related Public Records

Same Entity

Neurent Medical Limited
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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3012940012 Sutter Medical Technologies USA Inc. Alpharetta, GA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016813690. Last updated year: 2026. Please use registration number 3016813690 when referencing this establishment in official correspondence.
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